Skip to main content
OpenTrials
Completed

NCT Number: NCT05305534

QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Disease Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

QIAGEN

Manchester, United Kingdom

About this study

This multicenter study aims to evaluate the performance of QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel with another validated comparator method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU.
  • Residual and de-identified specimens.
  • Specimen from subject who has not previously been enrolled.
  • Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity.
  • Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity.
  • Minimum 1.5 mL volume available
  • In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales.

Exclusion criteria

  • Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids)
  • Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected).
  • Frozen specimens which are unable to be cultured after thawing.
  • Specimen from subject previously enrolled

Treatment and study plan

QIAstat-Dx® BCID GN and GPF Plus AMR Panels

Device

The performance of QIAstat-Dx® BCID GN and GPF Plus AMR Panels will be evaluated in comparison with another validated comparator method, using residual specimens of positive blood culture. Pure colonies derived from the residual positive blood culture specimens will also be tested

Primary outcomes

  1. PPA

    Time frame: 6 moths

    positive percentage agreement

  2. NPA

    Time frame: 6 moths

    negative percentage agreement

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Official study title

Clinical Performance Evaluation Study of the QIAstat-Dx® BCID GN and GPF Plus AMR Panels on Positive Blood Culture and Pure Colony Isolates From Subjects With Signs and Symptoms of Bloodstream Infection

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.